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NCT04108949

Small Children, Big Emotions

Terminated NA Last updated 22 December 2022
What this trial tests

NA trial testing Tuning in to Kids in Emotional Disturbances in 20 participants. Terminated before completion.

Timeline
15 August 2019
Primary endpoint
13 October 2021
13 October 2021

Quick facts

Lead sponsorUniversity Hospital, Akershus
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment20
Start date15 August 2019
Primary completion13 October 2021
Estimated completion13 October 2021
Sites3 locations across Norway

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Akershus

Who can join

Adults 2 to 5, any sex, with Emotional Disturbances. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a randomized controlled trial evaluating the clinical and cost-effectiveness of Tuning in to Kids (TIK) compared to treatment as usual (TAU). Participants are recruited among referred children aged 2-5 years with difficulties with emotion regulation. The study setting is Child and Adolescent Mental Health Services clinics. Parents of children randomized to TIK will attend 8 two-hourly group sessions. A brief version of TIK will be offered to the child's daycare teacher. Participants are assessed at baseline, week 12 and month 9 after inclusion. The primary clinical outcome is Coping with Toddlers' Negative Emotions Scale.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Tuning in to Kids

Trials testing the same drug.

Other recruiting trials for Emotional Disturbances

Currently open trials in the same condition.

Other University Hospital, Akershus trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing